Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors

Phase 1/2 Terminated 42 enrolled NewLink Genetics Corporation

Non-randomizedSequentialOpen-labelTreatment

Summary

A Phase 1/2a, open-label, dose-escalation study with enrollment in Phase 1 to continue until determination of the Maximum Tolerated Dose (MTD) /Recommended Phase 2a Dose (RP2D), and then enrollment into Phase 2a expansion cohorts will be initiated.

Timeline

Start: 2015-04
Primary completion: 2017-10-04
Completion: 2017-10-04

Outcome

Outcome not reported

Stopped: “Company decision”

Publications

Piha-Paul SA, Thein KZ, De Souza P, Kefford R, Gangadhar T, Smith C, Schuster S, Zamboni WC, Dees CE, Markman B. First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies. Invest New Drugs. 2021 Aug;39(4):1047-1056. doi: 10.1007/s10637-021-01081-x. Epub 2021 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CRLX301	Other / unclassified	7.5 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	15 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	25 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	30 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	35 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	45 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	54 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	60 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	75 mg/m2	Intravenous
Subject	CRLX301	Other / unclassified	90 mg/m2	Intravenous

Indications

No indication recorded.